Label: CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP- dextromethorphan hbr, doxylamine succinate solution

  • NDC Code(s): 68163-661-04
  • Packager: RARITAN PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

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  • ACTIVE INGREDIENT

    Active ingredients (in each 10 ml)Purposes

    Dextromethorphan HBr, USP 15 mg

    Cough suppressant

    Doxylamine Succinate, USP 6.25 mg

    Antihistamine
  • INDICATIONS & USAGE

    ▪
    Uses
    ▪
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    ▪
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ▪
    runny nose
    ▪
    sneezing
    ▪
    itchy, watery eyes
    ▪
    itching of the nose or throat
    ▪
    controls the impulse to cough to help you sleep
  • WARNINGS

    Warnings

    Do not use

    ▪
    to sedate a child or to make a child sleepy
    ▪
    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    ▪
    trouble urinating due to an enlarged prostate gland
    ▪
    glaucoma
    ▪
    a cough that occurs with too much phlegm (mucus)
    ▪
    a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    ▪
    do not use more than directed
    ▪
    marked drowsiness may occur
    ▪
    avoid alcoholic drinks
    ▪
    alcohol, sedatives, and tranquilizers may increase drowsiness
    ▪
    be careful when driving a motor vehicle or operating machinery
    ▪
    excitability may occur, especially in children

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    ▪
    measure only with dosing cup provided
    ▪
    keep dosing cup with product
    ▪
    ml = milliliter
    ▪
    do not take more than 4 doses in any 24-hour period
    agedose

    children under 6 years

    do not use

    children 6 to under 12 years

    10 ml every 6 hours

    adults and children 12 years and older

    20 ml every 6 hours

  • STORAGE AND HANDLING

    Other information

    •
    each 10 ml contains: sodium 2 mg
    •
    store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, natural flavor, organic honey, purified water, sodium benzoate,

  • QUESTIONS

    Questions or comments?

    1-866-467-2748

  • SPL UNCLASSIFIED SECTION

    Made in the U.S.A. with domestic and foreign ingredients

    Distributed by Lifelab Health LLC

    5300 W Hillsboro Blvd, Suite 202,

    Coconut Creek, FL 33073

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    NDC 68163-661-04

    HONEYWORKS™ Plus

    Children’s

    COUGH SYRUP

    Dextromethorphan HBr
    (COUGH SUPPRESSANT)
    Doxylamine Succinate (ANTIHISTAMINE)

    NIGHTTIME FORMULA

    GRAPE FLAVOR

    THIS GREAT-TASTING PRODUCT OFFERS FAST & EFFECTIVE COUGH RELIEF NAD IS MADE WITH ORGANIC DARK HONEY

    •
    NO PARABENS
    •
    NO DYES
    •
    NO HIGH FRUCTOSE CORN SYRUP
    •
    NO ARTIFICIAL FLAVORS
    •
    NON-GMO
    •
    SOY-FREE
    •
    GLUTEN FREE
    •
    DAIRY-FREE
    •
    PEANUT-FREE
    •
    TREE NUT-FREE
    •
    ZERO TRANS FAT

    FOR AGES 6 YEARS & OLDER

    ALSO TRY HONEYWORKS™ KIDS SOOTHING THROAT SPRAY

    4 FL OZ (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    Childrens Honeyworks NT cough DM 4 fl oz (118 ml)
  • INGREDIENTS AND APPEARANCE
    CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-661
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-661-041 in 1 CARTON02/01/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2023
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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